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First Meeting of the Subcommittee
of the Expert Committee
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Geneva, 9-13 July 2007 |
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Background information: | ||
Draft agenda for the Open Session (English // French)
Draft agenda (English // French)
WHA60.20: Better medicines for children
EB121.R2: Expert Committee on the Selection and Use of Essential Medicines: establishment of a subcommittee
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ITEM | Prepared by: | Comments |
Criteria for the selection of essential medicines for children |
Secretariat |
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Criteria for the selection of fixed-dose
combinations for essential medicines for children |
Secretariat | |
Paediatric age categories for essential medicines for children (DRAFT FOR DISCUSSION) |
FIP: David Knoppert (Canada, Michael Reed (US), Sandra Benavides (US), Joyce Totton (Canada), David Hoff (US), Brady Moffett (US), Kelley Norris (US), Regis Vaillancourt (Canada), Robert Aucoin (US), Mary Worthington (US) |
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Position paper on off-label use of essential medicines for children |
Madlen Gazarian MBBS, MSc(ClinEpi) FRACP, Sydney, Australia |
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Preferred dosage forms for essential medicines for children (DRAFT FOR DISCUSSION) |
FIP: Regis Vaillancourt (Canada), David Knoppert (Canada), Michael Reed (US), Sandra Benavides (US), Joyce Totton (Canada), David Hoff (US), Brady Moffett (US), Kelley Norris (US) |
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Secretariat |
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Review of other medicines listed in WHO treatment guidelines for children |
Secretariat |
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Review of regulatory initiatives designed to improve access to registered paediatric medicines: |
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National Institute of Child Health and Human Development National Institutes of Health, Bethesda, USA |
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Kalle Hoppu, MD PhD Poison Information Centre, Helsinki University Central Hospital, Hospital for Children and Adolescents and Dept. of Clinical Pharmacology, University of Helsinki, Helsinki, Finland |
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Review of the 1st draft of model list for essential medicines for children Background document: Core list Complementary list |
Secretariat |
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APPLICATIONS |
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Abacavir
(scored tablet 300 mg)
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GlaxoSmithKline (GSK) |
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Secretariat |
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Artemether |
Dr F.H. Jansen, Medical and R&D Director, Dafra Pharma nv, Slachthuisstraat 30 bus 7, B-2300 Turnhout, Belgium |
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Artemether + lumefantrine
(paediatric powder for oral liquid)
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Dr F.H. Jansen, Medical and R&D Director, Dafra Pharma nv, Slachthuisstraat 30 bus 7, B-2300 Turnhout, Belgium |
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Artesunate
(Rectal capsules containing 50 mg and 200 mg
sodium artesunate) |
Dr P. Olumese, Global Malaria Programme |
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Artesunate +
amodiaquine fixed-dose combination References: |
SANOFI-AVENTIS |
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Artesunate + mefloquine
fixed-dose combination
(Artequin™ Paediatric Stickpacks containing 50 mg artesunate + 125 mg mefloquine each) (Section 6.5.3.1. Antimalarial medicines, for curative treatment) Clinical summary // Clinical overview |
Dieter Meppiel, International Product Manager Malaria, Mepha Ltd., CH-4147 Aesch |
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Lamivudine
(scored
tablet 150 mg) |
GlaxoSmithKline (GSK) |
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Lamivudine + stavudine
+ nevirapine fixed-dose combination 40 mg + 10 mg + 70 mg (tablet for oral liquid) 20 mg + 5 mg + 35 mg (tablet for oral liquid) (Section 6.4.2. Antiretrovirals, fixed-dose combinations) |
Ranbaxy Laboratories Limited, India |
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Lamivudine
+ zidovudine + nevirapine fixed-dose combination
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Ranbaxy Laboratories Limited, India |
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Racecadotril Children of 3 months to 2 years of age: 16 sachets of 1 g powder containing 10 mg of racecadotril Children of 2 years to 15 years of age (approx.) : 16 or 30 sachets of 3 g powder containing 30 mg of racecadotril
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Jean-Guillaume Lecomte, Bioprojet Pharma, France |
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Respiratory tract infections, especially in children with HIV |
Secretariat |
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Secretariat |
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Subcutaneous
immunoglobulin //
Covering
letter
Appendix A:
Clinical study
//
Appendix
B:
Patients’
views on subcutaneous IgG (SCIG) Home Therapy //
Appendix C:
Safety
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Appendix D: Effectiveness
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Appendix E:
Cost-effectiveness //
Appendix F: Further experience
with subcutaneous immunoglobulin therapy in children with
primary immune deficiencies |
International Union of Immunological Societies [IUIS] |
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Update on oral rehydration solution constituents JAMA article: Symptomatic Hyponatremia During Treatment of Dehydrating Diarrheal Disease With Reduced Osmolarity Oral Rehydration Solution |
Secretariat | |
Zidovudine/lamivudine
fixed-dose combination
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GlaxoSmithKline (GSK) |
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Last update:01-Feb-2008